Proprio Receives FDA Clearance For the World’s First AI Surgical Guidance Platform

Real-Time Measurement and Guidance Set to Transform Surgery, Starting With World-Renowned Spine Centers Duke Health and UW Medicine

SEATTLE, April 8, 2025 /PRNewswire/ — Proprio, the global leader in AI-powered surgical technology, today announced that its AI guidance platform for surgery, Paradigm, has received its second major 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include intraoperative measurements. This is the first-ever technology that enables 3D, dynamic and segmental viewing of the anatomy, and marks the first time in history that surgeons will be able to measure success in real-time during surgery.

This milestone underscores the growing adoption of AI-driven surgical guidance among leading institutions, including Duke Health. “Duke continues to advance surgical innovation and utilize cutting-edge technologies to improve outcomes for our patients,” said Christopher I. Shaffrey, M.D., neurosurgeon and orthopedic surgeon at Duke Health and member of Proprio’s medical advisory board. “Our use of real-time 3D visualization enables us to measure critical outcomes like spinal alignment during procedures and reduces radiation exposure for operating teams.”

Prior to this clearance, surgeons were not able to easily measure progress to their goals during surgery. To take measurements during a procedure, doctors would have to scrub out and back in between taking X-rays and CT scans, leading to significant delays while patients were under anesthesia and losing blood. As a result, surgeons would commonly choose to keep surgery moving without delay and had to rely on preoperative measurements for planning and postoperative measurements to determine if they achieved their goals. 

“We’ve been using navigation in spine surgery for a while, but what this technology allows us to do is precisely find the right angle without intraoperative radiation and navigate it,” says Dr. Rick Bransford, a UW Medicine orthopedic surgeon at Harborview Medical Center. “The system can kind of tell us the trajectory and guidance to place screws with zero radiation.  This is a big deal, as almost all other forms of navigation require some component of intraoperative radiation. This next generation will also allow us to measure real-time change in segmental alignment without intraoperative radiation.  This means that not only can we ideally do a better job taking care of patients, but we can also better train our medical students, residents, fellows, and the next generation of surgeons,” Bransford said.

Now, the Paradigm AI platform shares real-time progress against pre-operative plans with continuous, accurate measurements, and lets surgeons know when they have achieved their goals. Using real-time data to inform decisions during surgery can save patients from several more revision surgeries and significantly improve outcomes altogether.

“Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing,” said Gabriel Jones, CEO and Co-Founder of Proprio. “Working with the best surgeons, Proprio is reshaping what’s possible in surgery and transforming healthcare with AI — not just automating tasks, but improving cognitive calibration, optimizing workflows for operating teams, robotics, and devices, while reducing the risk of adverse events. Our mission is to set a new standard of care that is 10 times more accessible and dramatically improves lives. Giving surgeons the visibility and data they need precisely when they need it is a huge leap forward in achieving our goals.”

Proprio’s real-time intraoperative measurements add to an unprecedented treasure trove of surgical data. With a comprehensive, multimodal dataset that has a clear view of surgery and is clean, labeled, and continuously refined with surgeon expertise in the loop, Proprio offers the most complete and factual view of surgery — creating new opportunities for training and clinical research. Hundreds of the world’s greatest spine, neuro, and orthopedic surgeons have already contributed their expertise to Proprio’s AI models, creating their digital legacy with every surgery, technique, and outcome recorded for future generations to learn from. 

This announcement comes following Proprio’s first FDA clearance for Paradigm.

About Proprio 

Proprio is the global leader in AI-powered surgical technology. The company’s flagship product, the Proprio Paradigm platform, revolutionizes the surgical process by providing AI-guided visualization and data-driven insights that improve precision, efficiency, and patient outcomes. For more information, visit proprio.ai.

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SOURCE Proprio